After final manufacturing, biopharmaceutical aqueous materials are often dispensed into containers to be frozen and later thawed and formulated or transported for further packaging into retail sized packaging. The dispensing occurs under sanitary conditions which involves the manual removal of the biopharmaceutical materials from a bulk reservoir (e.g., a 50 liter reservoir) into a plurality of smaller (e.g., 5 liter) containers in a clean environment which requires that workers wear appropriate clothing (e.g., sterile gowning, hoods, gloves, sleeves, etc.) and a positive pressure laminar flow hood (e.g., an ISO 5 class hood) which pushes single-pass filtered air out of the hood in order to prevent any accumulation of particulates or microbes in the environment in which the dispensing of the biopharmaceutical materials is being performed. Actual dispensing of biopharmaceutical materials is performed by removing the caps of the receiving containers within the hood, then pumping the biopharmaceutical material from a bulk container into each open bottle. Upon achieving a certain volume, each bottle is then capped and removed from the hood. A sample may be taken of the dispensed biopharmaceutical materials at some point during the process of removing the biopharmaceutical materials from the bulk reservoir and dispensing into smaller containers by dispensing the material into a separate sampling container. This sample may be tested to ensure the integrity of the biopharmaceutical materials prior to the freezing and/or final packaging thereof in smaller containers or prior to the transfer into retail-sized packaging, for example. Such sampling may be performed at various intervals during the dispensing process resulting in such samples being more or less representative of the product dispensed into the receiving containers. Further, during the filling process, monitoring of the material dispensed in an ambient environment inside the flow hood may be performed to ensure the integrity of the process.
The described dispensing requires that the biopharmaceutical materials be exposed to the uncertainties of open-air dispensing and the uncertainties of manual dispensing by a plurality of individuals required to perform such dispensing. Such uncertainties could lead to contamination of the biopharmaceutical materials and potential danger to a patient having such contaminated materials administered thereto.
Thus, there is a need for systems and methods for dispensing biopharmaceutical materials, which minimize a risk of contamination of the biopharmaceutical materials when it is transferred from a final processing container to plurality of containers for further transport thereof.